Apomorphine sublingual film was evaluated in a Phase 3, randomized, double-blind, placebo-controlled, parallel group clinical trial, CTH-300, that involved patients with PD who experienced motor fluctuations (OFF episodes). The primary endpoint was achieved with data demonstrating a statistically significant mean reduction in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score from pre-dose to 30 minutes post-dose at Week 12, as compared with placebo. These effects lasted until the last observed time point at 90 minutes. The difference in score change from baseline to 30 minutes post-dose between the apomorphine and placebo group was 7.6 (P=0.0002).
The major secondary endpoint was met with data demonstrating a statistically significant greater percentage of apomorphine-treated patients having a patient-rated full ON response within 30 minutes post-dose at Week 12, as compared with placebo (35% vs 16%). The study drug was also generally well-tolerated by patients. Nausea, somnolence, dizziness, yawning, and headache were reported as the most common treatment-emergent adverse events.
Apomorphine SL film, a dopamine agonist, is being developed for the treatment of all motor OFF episodes, including morning OFF, unpredictable OFF, and end-of-dose wearing OFF. It is intended for on-demand adjunct therapy with patients’ current levodopa treatment regimens to manage OFF episodes.
Primary study investigator, Stewart Factor, DO, Professor of Neurology, Director of the Movement Disorders Program and Vance Lanier Chair of Neurology at Emory University School of Medicine, stated, “The study reported here demonstrated that sublingual apomorphine rapidly and safely converted people with Parkinson’s disease from the OFF to the ON state.”
Apomorphine SL film has been granted Fast Track Designation by the FDA and a New Drug Application (NDA) submission is planned for Spring 2018.
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